Regulatory Guidance

Resources

Although the purpose of an IRB is to protect human research subjects, an IRB cannot do this alone. The IRB should be an integrated part of a larger program. Generically such programs are called HRPPs or Human Research Protection Programs.

HRPPs were spoken of only casually prior to about 2000, at which point the OHRP, under Dr. Greg Koski, encouraged their development. HRPPs are a key concept in OHRP assurance policies and the AAHRPP accreditation concepts.

Although development of a HRPP is conceptually simple within a single institution, it is infinitely more difficult in a virtual environment. An HRPP should encompass several functions: